Described herein is a pharmaceutical composition comprising lamotrigine as an active ingredient providing a prolonged release characteristic to allow once a day dosage regime. The composition comprises lamotrigine and a swelling agent forming a core or an extended-release composition. The core or an extended-release composition may be coated with a hydrophobic, pH-independent polymer to provide a modified extended-release composition. The formulation may comprise other pharmaceutically acceptable excipients that may act as additional release rate modifier(s), e.g., a pore forming agent in the hydrophobic polymer coat/film. Also described are the processes of preparing such dosage forms and their use.本文闡述包含拉莫三嗪(Lamotrigine)作為活性成分並提供延緩釋放特徵,以允許每天一次劑量方案之醫藥組合物。該組合物包含形成核心或延長釋放組合物之拉莫三嗪及膨脹劑。可利用疏水性之非pH依賴性聚合物塗覆該核心或延長釋放組合物,以提供改良之延長釋放組合物。該調配物可包含其他醫藥上可接受之賦形劑作為額外之釋放速率改良劑,例如含於疏水性聚合物塗層/膜中之成孔劑。本文亦闡述製備該等劑型之方法及其用途。
